The Effect of Long-Acting Mesalamine on Post-Infective Irritable Bowel Syndrome- A Pilot Study
Information source: University of Utah
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Post Infective IBS-D; Irritable Bowel Syndrome With Diarrhea
Intervention: Mesalamine (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: University of Utah Official(s) and/or principal investigator(s):
Ashok Tuteja, Principal Investigator, Affiliation: Gastroenterology
Overall contact:
Andrew Grandemange, Phone: 801-587-9092, Email: Andrew.Grandemange@hsc.utah.edu
Summary
The purpose of this study is to evaluate the effects of long acting mesalamine (Lialda) in
patients with Post-Infective Irritable Bowel Syndrome (PI-IBS). The investigators will
evaluate gastrointestinal symptoms, IBS specific quality of life (IBS-QOL), and plasma
cytokines before and after treatment with Lialda.
This study will test long acting mesalamine in the management of PI-IBS. It has the
potential to improve QOL and perhaps gastrointestinal symptoms, in patients with PI-IBS.
The results of this study, if positive, will provide preliminary data for a large scale
clinical trial.
This study will also provide information about plasma cytokines in patients with PI-IBS and
whether improvement in symptoms correlates with improvement in plasma cytokines.
Clinical Details
Official title: The Effect of Long-Acting Mesalamine on Post-Infective Irritable Bowel Syndrome- A Pilot Study
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Change from baseline in gastrointestinal symptoms and IBS specific quality of life after an 8 week treatment period
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Inclusion Criteria
1. Men and women age 18-75 years
2. Rome III criteria for IBS
3. Symptom onset after apparent acute gastroenteritis
4. Symptoms of 6 months or greater duration
5. Normal gross appearance of the colonic mucosa other than erythema
6. Negative markers for celiac disease and inflammatory bowel disease
7. Normal thyroid function and serum calcium
8. Stable medication regimens for other medical conditions.
Exclusion Criteria:
1. Age <18 or >75 years
2. Previous diagnosis of or history compatible with IBS
3. Constipation-predominant IBS.
4. Clinically significant chronic cardiac, pulmonary, hepatic, renal dysfunction or HIV
5. History of/or presence of malignancy
6. Current evidence of any gastrointestinal disorder such as celiac disease,
inflammatory bowel disease, chronic pancreatitis, scleroderma, HIV, small bowel or
colonic resection, paraplegia or quadriplegia. .
7. Current evidence of drug or alcohol abuse as judged by the investigator
8. Allergy to mesalamine or aspirin
9. Investigator perception of patient's inability to comply with the study protocol
10. Unstable psychiatric disease
11. Recent change in gastrointestinal medications
Locations and Contacts
Andrew Grandemange, Phone: 801-587-9092, Email: Andrew.Grandemange@hsc.utah.edu
University of Utah, Salt Lake City, Utah 84132, United States; Recruiting
Andrew Grandemange, Phone: 801-587-9092, Email: Andrew.Grandemange@hsc.utah.edu
Ashok Tuteja, M.D., Principal Investigator
Additional Information
Starting date: June 2010
Last updated: June 4, 2012
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